The factors associated with poor short-term recovery from knee surgery appear to be different than those found to mar long-term outcome from the same surgery, according to new research released at the 2007 Annual Meeting of the American Orthopaedic Society for Sports Medicine at the Telus Convention Center.
"We found that women showed poorer short-term recovery than men in the first year following arthroscopic meniscal tear removal surgery, and people with osteoarthritis also did not do as well as others," says principal investigator Peter Fabricant, BS, a medical student at Yale University School of Medicine in New Haven, Conn. "The factors associated with a poorer long-term outcome, such as larger tear size, greater amount of tissue removed, advanced patient age, and higher Body Mass Index, are not the same as those we can associate with short-term surgical recovery."
The meniscus is the shock-absorbing tissue that cushions the knee joint preventing the bones from rubbing. Tears in this tissue can cause pain and loss of function. In arthroscopic partial meniscectomy, the surgeon inserts small surgical instruments and a camera through tiny incisions in the knee to remove torn tissue. An estimated 636,000 arthroscopic knee procedures are performed annually, according to the American Academy of Orthopaedic Surgeons.
Fabricant and colleagues at Yale University studied 126 patients who underwent arthroscopic partial meniscectomy to assess the impact of obesity, age, gender, amount of tissue removed, and degenerative joint changes on short-term recovery. They found that being female and the extent of osteoarthritis were associated with a less-than-optimal first-year recovery.
Other studies have shown that advanced age, obesity, and the amount of meniscal tissue removed all negatively affect long-term outcome from arthroscopic meniscal repair. "In our study these variables did not affect short-term recovery. Conversely, gender and osteoarthritis appear to play a role in short-term recovery, as they have been shown to do in the long-term," Fabricant comments.
The current medical literature only offers research findings on long-term outcomes following arthroscopic meniscal repair. "We couldn't find anything in the literature to predict recovery during the first year," explains Fabricant. "Physicians need to be able to discuss with patients how long it might be before they can return to optimal function levels in work and activities of daily living."
Fabricant and colleagues suggest that severe osteoarthritis in the knee may be a contraindication to surgery. "Arthritis may be a marker for a degenerated knee, which may not be able to recover as well as a healthy, non-arthritic knee," Fabricant says.
Osteoarthritis may also be a marker for worse overall knee function in general. Patients with severe osteoarthritis already have loss of cartilage and soft tissue. Further tissue removal appears to have minimal impact on patient knee pain and function during the year following surgery.
The investigators say that it is unclear exactly how female gender complicates surgical recovery. Fabricant notes that there are gender differences both in surgical outcome and possibly in the biomechanics resulting in how the knee was initially injured. Even before surgery, women typically reported more knee pain and decreased knee function compared to men.
The American Orthopaedic Society for Sports Medicine (AOSSM), a world leader in sports medicine education, research, communication and fellowship, is an organization of orthopaedic sports medicine specialists, including national and international sports medicine leaders. The Society works closely with many other sports medicine specialists including athletic trainers, physical therapists, family physicians, and others to improve the identification, prevention, treatment, and rehabilitation of sports injuries. Please visit the AOSSM Web site, sportsmed/.
Contact: Patti Davis
American Orthopaedic Society for Sports Medicine
понедельник, 29 августа 2011 г.
пятница, 26 августа 2011 г.
The best treatment strategy for early rheumatoid arthritis - what is it?
Study shows long-term benefits of initial combination therapy, including either prednisone or infliximab, over dmards alone or step-up combination therapy -
A progressive, inflammatory disease affecting the joints and organs, rheumatoid arthritis (RA) claims more than two million Americans, mostly women over age 40, among its victims. While a cure has yet to be found, the treatment of RA patients has changed considerably over the last two decades. Today, the goal of therapy is not simply symptom relief, but the prevention of long-term structural damage and functional decline. Toward this end, various disease-modifying antirheumatic drugs (DMARDs) have been proven effective in clinical trials, on their own and in tandem with various tumor necrosis factor (TNF) antagonists. While the recent increase in therapeutic options offers much promise, it has left doctors grappling with the question: What is the best treatment strategy for a patient newly diagnosed with RA?
The results of a long-term study, featured in the November 2005 issue of Arthritis & Rheumatism (interscience.wiley/journal/arthritis), provide clear answers. A team of researchers in the Netherlands compared the four most widely sanctioned and commonly prescribed treatment strategies for very early RA on 508 patients. Primarily women, with a mean age of 54, the patients had suffered disease symptoms for an average of 23 weeks before entering the trial. After randomly assigning the patients to one of four treatment strategies, the researchers closely monitored the effects and benefits for each group over the course of one year.
Group 1 (126 patients) received standard DMARD therapy, starting with methotrexate. Group 2 (121 patients) was assigned to step-combination therapy, starting with methotrexate only, adding other DMARDs and prednisone. Group 3 (133 patients) started with a combination of methotrexate, sulphasalazine and prednisone. Group 4 (128 patients) started with a combination of methotrexate and infliximab. For all groups, drug dosages were increased or switched to other (combinations of) drugs according to the treatment protocol to achieve a state of low disease activity.
At the end of the year, every group demonstrated measurable improvements, with 32 percent of all the patients achieving clinical remission of their disease. However, patients who had received initial combination therapy--either with prednisone (group 3) or with infliximab (group 4)--had significantly less progression of radiographic joint damage than did patients treated with DMARDs only (group 1), or patients assigned to step-up combination therapy (group 2). The number of patients without any progression of radiographic joint damage was also higher in groups 3 and 4 than in groups 1 and 2. Furthermore, RA patients in both initial combination therapy groups experienced earlier functional improvement than did patients in either the DMARD monotherapy or step-up combination therapy group, according to scores of the Dutch version of the Health Assessment Questionnaire. Overall, patients who received initial combination therapy experienced no more side effects than patients in the other two groups.
"Patients in groups 3 and 4 had the benefit of a more rapid relief of symptoms and improvement of physical function," observes the author, B. A. C. Dijkmans, M.D. "In addition, there is the possibility that effective suppression of disease activity during the early phases of the disease may ameliorate the long-term joint damage and poor physical function and, ideally, even induce true clinical remission without the need for ongoing DMARD treatment."
Should any patient with newly diagnosed RA be treated with a single DMARD? Would choosing this established course always make a patient vulnerable to increased disease severity? That question can only be answered with further research.
Article: "Clinical and Radiographic Outcomes of Four Different Treatment Strategies in Patients With Early Rheumatoid Arthritis (the BeSt Study): A Randomized, Controlled Trial," Y. P .M. Goekoop-Ruiterman, J. K. de Vries-Bouwstra, C. F. Allaart, D. van Zeben, P. J. S. M. Kerstens, J. M. W. Hazes, A. H. Zwinderman, H. K. Ronday, K. H. Han, M. L. Westedt, A. H. Gerards, J. H. L. M. van Groenendael, W. F. Lems, M. V. van Krugten, F. C. Breedveld, and B. A. C. Dijkmans, Arthritis & Rheumatism, November 2005; 52:11; pp. 3381-3390.
John Wiley & Sons, Inc.
interscience.wiley
A progressive, inflammatory disease affecting the joints and organs, rheumatoid arthritis (RA) claims more than two million Americans, mostly women over age 40, among its victims. While a cure has yet to be found, the treatment of RA patients has changed considerably over the last two decades. Today, the goal of therapy is not simply symptom relief, but the prevention of long-term structural damage and functional decline. Toward this end, various disease-modifying antirheumatic drugs (DMARDs) have been proven effective in clinical trials, on their own and in tandem with various tumor necrosis factor (TNF) antagonists. While the recent increase in therapeutic options offers much promise, it has left doctors grappling with the question: What is the best treatment strategy for a patient newly diagnosed with RA?
The results of a long-term study, featured in the November 2005 issue of Arthritis & Rheumatism (interscience.wiley/journal/arthritis), provide clear answers. A team of researchers in the Netherlands compared the four most widely sanctioned and commonly prescribed treatment strategies for very early RA on 508 patients. Primarily women, with a mean age of 54, the patients had suffered disease symptoms for an average of 23 weeks before entering the trial. After randomly assigning the patients to one of four treatment strategies, the researchers closely monitored the effects and benefits for each group over the course of one year.
Group 1 (126 patients) received standard DMARD therapy, starting with methotrexate. Group 2 (121 patients) was assigned to step-combination therapy, starting with methotrexate only, adding other DMARDs and prednisone. Group 3 (133 patients) started with a combination of methotrexate, sulphasalazine and prednisone. Group 4 (128 patients) started with a combination of methotrexate and infliximab. For all groups, drug dosages were increased or switched to other (combinations of) drugs according to the treatment protocol to achieve a state of low disease activity.
At the end of the year, every group demonstrated measurable improvements, with 32 percent of all the patients achieving clinical remission of their disease. However, patients who had received initial combination therapy--either with prednisone (group 3) or with infliximab (group 4)--had significantly less progression of radiographic joint damage than did patients treated with DMARDs only (group 1), or patients assigned to step-up combination therapy (group 2). The number of patients without any progression of radiographic joint damage was also higher in groups 3 and 4 than in groups 1 and 2. Furthermore, RA patients in both initial combination therapy groups experienced earlier functional improvement than did patients in either the DMARD monotherapy or step-up combination therapy group, according to scores of the Dutch version of the Health Assessment Questionnaire. Overall, patients who received initial combination therapy experienced no more side effects than patients in the other two groups.
"Patients in groups 3 and 4 had the benefit of a more rapid relief of symptoms and improvement of physical function," observes the author, B. A. C. Dijkmans, M.D. "In addition, there is the possibility that effective suppression of disease activity during the early phases of the disease may ameliorate the long-term joint damage and poor physical function and, ideally, even induce true clinical remission without the need for ongoing DMARD treatment."
Should any patient with newly diagnosed RA be treated with a single DMARD? Would choosing this established course always make a patient vulnerable to increased disease severity? That question can only be answered with further research.
Article: "Clinical and Radiographic Outcomes of Four Different Treatment Strategies in Patients With Early Rheumatoid Arthritis (the BeSt Study): A Randomized, Controlled Trial," Y. P .M. Goekoop-Ruiterman, J. K. de Vries-Bouwstra, C. F. Allaart, D. van Zeben, P. J. S. M. Kerstens, J. M. W. Hazes, A. H. Zwinderman, H. K. Ronday, K. H. Han, M. L. Westedt, A. H. Gerards, J. H. L. M. van Groenendael, W. F. Lems, M. V. van Krugten, F. C. Breedveld, and B. A. C. Dijkmans, Arthritis & Rheumatism, November 2005; 52:11; pp. 3381-3390.
John Wiley & Sons, Inc.
interscience.wiley
вторник, 23 августа 2011 г.
Interleukin Genetics Initiates Study Of Genetics Of Osteoarthritis With New York University Medical Center
Interleukin Genetics,
Inc. (Amex: ILI) announced today that it has initiated a study on the
genetics of osteoarthritis in collaboration with Dr. Steven Abramson,
Director of the Division of Rheumatology at the Hospital for Joint Diseases
of New York University Medical Center.
Osteoarthritis (OA) is the breakdown of the cartilage cushion in one or
more joints of the body leading to pain, to limitation in movement, and in
many cases to joint replacement. More than 20 million adults in the United
States currently have some form of OA, with the number expected to double
over the next 50 years. Therapy for OA patients involves mostly pain
management, and no drugs are currently available to limit the cartilage and
bone destruction.
Some patients have OA in one joint that may have resulted from a prior
injury, but many OA patients have a more generalized form of the disease
affecting multiple joints. The generalized form of OA is often the most
challenging in terms of patient management.
"We have been working for several years to better understand why some
of our patients develop a more generalized form of OA with problems in
multiple joints," said Dr. Abramson. "Together with Interleukin Genetics we
will seek to determine if over-expression of certain disease-related
chemicals by some OA patients may be due to genetic differences, and
whether the genetic differences may increase the likelihood of developing
disease in multiple joints."
"Interleukin Genetics is pleased to be working with Dr. Abramson and
his team at the Hospital for Joint Diseases at NYU Medical Center," said
Dr. Ken Kornman, Chief Scientific Officer of Interleukin Genetics. "OA
impacts tens of millions of people around the world, who can now only turn
to pain medication for temporary relief. We have identified genetic
patterns that lead to over-production of interleukin-1, one of the key
chemicals involved in cartilage and bone destruction, and this study will
help to determine if genetic tests can be used to identify subgroups of OA
patients that may be treated more effectively."
About the Study
Interleukin Genetics is investigating whether there is an association
between candidate gene variations, either individually or in composite
patterns, and poly-articular manifestations of osteoarthritis (OA), defined
in this study as the prevalence of knee and hand OA. The study will also
evaluate the association between certain genetic patterns and the
peripheral blood mononuclear cell expression of interleukin-1 Beta in OA
patients. Interleukin-1 Beta is one of the main chemicals involved in
destruction of collagen and bone.
Variations in the interleukin-1 (IL-1) gene family have been shown to
be associated with increased risk for other diseases that involve bone and
connective tissues, including osteoporosis and periodontal disease. Using
its proprietary IL-1 technology, Interleukin Genetics is now collaborating
with NYU Medical Center and the Division of Rheumatology to study IL-1
genetic links to the form of osteoarthritis that affects multiple joints
and may be the result of a systemic over-expression of key biological
mediators, such as interleukin-1 Beta.
This study is under the direction of Dr. Steven Abramson, Director of
the Division of Rheumatology and Dr. Mukundan Attur, Director of the
Rheumatology Research Laboratory at the New York University Hospital for
Joint Diseases.
Osteoarthritis
Osteoarthritis (OA) is the most common adult joint disease, increasing
in frequency and severity in all aging populations. The estimated U.S.
prevalence is 20-40 million patients or 5 times that of rheumatoid
arthritis. OA involvement of the hand, knee, hip and spine is common, with
total knee replacements numbering over 250,000/yr and total hip
replacements numbering over 150,000 per year in the U.S. alone. OA may
involve a single joint or multiple joints in the same individual, with
current therapy focused on pain relief as there is no FDA-approved therapy
that arrests or reverses the joint deterioration. The etiology of OA is
multifactorial involving both mechanical and biochemical factors. OA
progression is associated with accelerated cartilage degradation leading to
joint space narrowing, painful joint disruption, and functional compromise.
The pattern of expression for OA in many ways mimics that of osteoporosis
in that it is more common in women than in men, and it appears to be
related to postmenopausal changes with hormone replacement therapy
suppressing cartilage degradation. OA disease progression is characterized
by a proinflammatory gene expression pattern in cartilage and in joint
synovium, with a reactive increase in bone density in the subchondral bone.
Substantial data provide support for a central role of interleukin-1 in the
pathogenesis of OA including animal susceptibility models and models of
IL-1-targeted therapy.
About Interleukin
Interleukin Genetics, Inc. (Amex: ILI) is a genetics-focused
personalized health company that develops preventive consumer products and
genetic tests for sale to the emerging personalized health market. Focused
on the future of health and medicine, Interleukin uses its leading genetics
research and scientific capabilities to develop and test innovative
preventive and therapeutic products. Interleukin currently offers an array
of Nutraceuticals and OTCeuticals, including Ginkoba(R), Ginsana(R) and
Venastat(R) which are sold at the nation's largest food, drug and mass
retailers, and has commercialized genetic tests for periodontal disease
risk assessment, cardiovascular risk assessment, and general nutrition
assessment. Interleukin is headquartered in Waltham, MA. For more
information about Interleukin and its ongoing programs, please visit
ilgenetics.
Certain statements contained herein are "forward-looking" statements
including statements regarding our ability to develop diagnostic,
personalized nutritional and therapeutic products to prevent or treat
diseases of inflammation and other genetic variations, our ability to
screen nutritional compounds for their effects on inflammatory responses
and other genetic variations, given specific genetic patterns and our
ability to make progress in advancing our core technologies. Because such
statements include risks and uncertainties, actual results may differ
materially from those expressed or implied by such forward-looking
statements. Factors that could cause actual results to differ materially
from those expressed or implied by such forward- looking statements
include, but are not limited to, the risk of market acceptance of our
products, the risk of technology and product obsolescence, delays in
product development, the performance of our commercial partners, the
availability of adequate capital, the actions of our competitors and other
competitive risks, and those risks and uncertainties described in our
annual report on Form 10-K for the year ended December 31, 2006 as amended,
filed with the Securities and Exchange Commission, our quarterly reports on
Form 10- Q and other filings made by us with the Securities and Exchange
Commission. We disclaim any obligation or intention to update these
forward-looking statements.
Interleukin Genetics, Inc.
ilgenetics
Inc. (Amex: ILI) announced today that it has initiated a study on the
genetics of osteoarthritis in collaboration with Dr. Steven Abramson,
Director of the Division of Rheumatology at the Hospital for Joint Diseases
of New York University Medical Center.
Osteoarthritis (OA) is the breakdown of the cartilage cushion in one or
more joints of the body leading to pain, to limitation in movement, and in
many cases to joint replacement. More than 20 million adults in the United
States currently have some form of OA, with the number expected to double
over the next 50 years. Therapy for OA patients involves mostly pain
management, and no drugs are currently available to limit the cartilage and
bone destruction.
Some patients have OA in one joint that may have resulted from a prior
injury, but many OA patients have a more generalized form of the disease
affecting multiple joints. The generalized form of OA is often the most
challenging in terms of patient management.
"We have been working for several years to better understand why some
of our patients develop a more generalized form of OA with problems in
multiple joints," said Dr. Abramson. "Together with Interleukin Genetics we
will seek to determine if over-expression of certain disease-related
chemicals by some OA patients may be due to genetic differences, and
whether the genetic differences may increase the likelihood of developing
disease in multiple joints."
"Interleukin Genetics is pleased to be working with Dr. Abramson and
his team at the Hospital for Joint Diseases at NYU Medical Center," said
Dr. Ken Kornman, Chief Scientific Officer of Interleukin Genetics. "OA
impacts tens of millions of people around the world, who can now only turn
to pain medication for temporary relief. We have identified genetic
patterns that lead to over-production of interleukin-1, one of the key
chemicals involved in cartilage and bone destruction, and this study will
help to determine if genetic tests can be used to identify subgroups of OA
patients that may be treated more effectively."
About the Study
Interleukin Genetics is investigating whether there is an association
between candidate gene variations, either individually or in composite
patterns, and poly-articular manifestations of osteoarthritis (OA), defined
in this study as the prevalence of knee and hand OA. The study will also
evaluate the association between certain genetic patterns and the
peripheral blood mononuclear cell expression of interleukin-1 Beta in OA
patients. Interleukin-1 Beta is one of the main chemicals involved in
destruction of collagen and bone.
Variations in the interleukin-1 (IL-1) gene family have been shown to
be associated with increased risk for other diseases that involve bone and
connective tissues, including osteoporosis and periodontal disease. Using
its proprietary IL-1 technology, Interleukin Genetics is now collaborating
with NYU Medical Center and the Division of Rheumatology to study IL-1
genetic links to the form of osteoarthritis that affects multiple joints
and may be the result of a systemic over-expression of key biological
mediators, such as interleukin-1 Beta.
This study is under the direction of Dr. Steven Abramson, Director of
the Division of Rheumatology and Dr. Mukundan Attur, Director of the
Rheumatology Research Laboratory at the New York University Hospital for
Joint Diseases.
Osteoarthritis
Osteoarthritis (OA) is the most common adult joint disease, increasing
in frequency and severity in all aging populations. The estimated U.S.
prevalence is 20-40 million patients or 5 times that of rheumatoid
arthritis. OA involvement of the hand, knee, hip and spine is common, with
total knee replacements numbering over 250,000/yr and total hip
replacements numbering over 150,000 per year in the U.S. alone. OA may
involve a single joint or multiple joints in the same individual, with
current therapy focused on pain relief as there is no FDA-approved therapy
that arrests or reverses the joint deterioration. The etiology of OA is
multifactorial involving both mechanical and biochemical factors. OA
progression is associated with accelerated cartilage degradation leading to
joint space narrowing, painful joint disruption, and functional compromise.
The pattern of expression for OA in many ways mimics that of osteoporosis
in that it is more common in women than in men, and it appears to be
related to postmenopausal changes with hormone replacement therapy
suppressing cartilage degradation. OA disease progression is characterized
by a proinflammatory gene expression pattern in cartilage and in joint
synovium, with a reactive increase in bone density in the subchondral bone.
Substantial data provide support for a central role of interleukin-1 in the
pathogenesis of OA including animal susceptibility models and models of
IL-1-targeted therapy.
About Interleukin
Interleukin Genetics, Inc. (Amex: ILI) is a genetics-focused
personalized health company that develops preventive consumer products and
genetic tests for sale to the emerging personalized health market. Focused
on the future of health and medicine, Interleukin uses its leading genetics
research and scientific capabilities to develop and test innovative
preventive and therapeutic products. Interleukin currently offers an array
of Nutraceuticals and OTCeuticals, including Ginkoba(R), Ginsana(R) and
Venastat(R) which are sold at the nation's largest food, drug and mass
retailers, and has commercialized genetic tests for periodontal disease
risk assessment, cardiovascular risk assessment, and general nutrition
assessment. Interleukin is headquartered in Waltham, MA. For more
information about Interleukin and its ongoing programs, please visit
ilgenetics.
Certain statements contained herein are "forward-looking" statements
including statements regarding our ability to develop diagnostic,
personalized nutritional and therapeutic products to prevent or treat
diseases of inflammation and other genetic variations, our ability to
screen nutritional compounds for their effects on inflammatory responses
and other genetic variations, given specific genetic patterns and our
ability to make progress in advancing our core technologies. Because such
statements include risks and uncertainties, actual results may differ
materially from those expressed or implied by such forward-looking
statements. Factors that could cause actual results to differ materially
from those expressed or implied by such forward- looking statements
include, but are not limited to, the risk of market acceptance of our
products, the risk of technology and product obsolescence, delays in
product development, the performance of our commercial partners, the
availability of adequate capital, the actions of our competitors and other
competitive risks, and those risks and uncertainties described in our
annual report on Form 10-K for the year ended December 31, 2006 as amended,
filed with the Securities and Exchange Commission, our quarterly reports on
Form 10- Q and other filings made by us with the Securities and Exchange
Commission. We disclaim any obligation or intention to update these
forward-looking statements.
Interleukin Genetics, Inc.
ilgenetics
суббота, 20 августа 2011 г.
Future hope for patients with Rheumatoid Arthritis, Targeting 'B-Cells' a new approach to RA treatment
New data in New England Journal of Medicine show MabThera(reg) (rituximab) is effective in rheumatoid arthritis patients that have failed current therapy.
The New England Journal of Medicine (NEJM) today publishes a study which offers future hope for the thousands of rheumatoid arthritis (RA) patients who are not responding to currently available treatments (Disease Modifying Anti-Rheumatic Drugs (DMARDs)).
The multicentre study demonstrated that just two doses of MabThera(reg) (rituximab) two weeks apart, in combination with methotrexate (MTX), significantly improved symptoms in patients with severe RA by up to 70%, with response rates sustained for up to one year.
Unlike other RA treatments, MabThera is a targeted treatment that selectively seeks and destroys particular B cells (also known as B-lymphocytes).
"At the National Rheumatoid Arthritis Society we are excited and encouraged by this data. It looks as if MabThera could be an important new option in the future for patients living with Rheumatoid Arthritis in the UK.
Knowing there are other new drugs in the pipeline gives patients who are failing on current therapies hope." Ailsa Bosworth, Chief Executive National Rheumatoid Arthritis Society.
B-cells - a new approach to RA
As research advances into the causes of RA a new approach is emerging. Historically, B cells were considered to contribute to RA - however for much of the past 20 years, it has generally been considered a T-cell mediated disease.
However, new scientific evidence has rekindled a strong interest in B cells, which appear to play an important role in the pathogenesis of RA, suggesting B cells are a promising target for the development of successful treatments.
"The study provides strong support for the idea that B lymphocytes play a central role in rheumatoid arthritis and suggests that B lymphocyte targeted therapy has significant potential", said Professor Jonathan Edwards, University College of London, UK, lead investigator for the study.
MabThera is the only treatment for RA that specifically targets B-Cells.
About the study
In this Phase II study, investigators followed patients for 6 months, with a further observation at 12 months assessing the response with MabThera(reg) alone or in combination with cyclophosphamide or MTX, compared to MTX alone.
The results at 24 weeks showed that the proportion of patients reaching at least a 50% improvement in disease scores (ACR 50 - the primary endpoint) was significantly greater in the MabThera(reg) treated groups compared with the control. Moreover, a significantly higher percentage of patients treated with MabThera(reg) plus MTX achieved a 70% improvement in symptoms (ACR 70).
According to the investigators, the study's safety profile indicates that all three MabThera(reg) regimens were well tolerated with similar levels and type of adverse events compared to MTX alone. Most adverse events were reported during the initial 15 days, with most more likely to occur with the first infusion of MabThera(reg).
The majority of events were of mild to moderate intensity. At week 48, the incidence and types of events, including infections, were evenly balanced across all groups.
About MabThera(reg)
MabThera(reg) (rituximab) is a genetically engineered, therapeutic monoclonal antibody that binds specifically to the CD20 protein found on the surface of B cells.
By selectively targeting B cells, MabThera(reg) breaks the inflammatory cascade of RA - a series of reactions inflaming the joints and leading to the cartilage loss and bone erosion that is characteristic of the disease, the new theory is that B cells play a key role in this inflammatory cascade.
MabThera, known as the 'magic bullet for cancer' has been widely used in clinical practice in the UK for over 6 years for treatment of a form of lymphatic cancer called non-Hodgkin's lymphoma (NHL). More than 370,000 patients worldwide have been treated with MabThera(reg) to date.
Rheumatoid Arthritis
RA affects over 400,000 people in the UK, which is a debilitating disease that hinders the daily activities of sufferers. Although primarily RA affects persons over 64 a significant proportion are aged between 45 and 64.
RA is characterized by inflammation of multiple joints, cartilage loss and bone erosion, which leads to joint destruction and ultimately, reduced joint function. Additionally, since RA is a systemic disease, it can have effects on other tissues, such as lungs, eyes and bone marrow. After ten years of RA, fewer than 50% of patients can continue to work or function normally on a day to day basis. In the UK alone this results in a loss of ??833 million in production costs.
MabThera is not currently licensed for use in rheumatoid arthritis in the United Kingdom
- Ends -
For further information:
Denise Reid-Bashir / Joanna Dixon
Cohn and Wolfe
Tel: +44 20 7331 5337 / +44 20 7331 5321
Mobile: +44 7947 259 41
Rebecca Hunt/Helen Brown
Roche UK
(UK) 01707 367 551/01707 366 805
(UK) 07786 171 214
Notes to editors - results of the NEJM Publication
Response rates at 24 weeks, when using MabThera??? / Rituxan??? in combination with MTX included:
-- 73% of patients showed at least a 20% improvement in symptoms (ACR 20, p=0.003 vs. MTX alone)
-- 43% showed at least a 50% improvement in symptoms (ACR 50 p=0.005 vs MTX alone)
-- 23% showed at least a 70% improvement in symptoms (ACR 70 p=0.048 vs MTX alone)
-- Peripheral blood immunoglobulin levels remained within the normal range throughout and MabThera??? / Rituxan??? was well tolerated with a favorable safety profile
In a further analysis, similar response rates were maintained up to at least 48 weeks without further MabThera??? / Rituxan??? treatment, in the MabThera??? / Rituxan??? plus MTX group, with ACR 20 in 65%, ACR 50 in 35% and ACR 70 in 15%.
Results from the other three arms of the study at 48 weeks include:
-- MTX alone: 20% of patients experienced a 20% improvement in symptoms and 5% experienced a 50% improvement; none experienced 70% improvement
-- MabThera??? / Rituxan??? alone: 33% experienced a 20% improvement, 15% experienced a 50% improvement and 10% experienced a 70% improvement
-- MabThera??? / Rituxan??? and cyclophosphamide: 49% experienced a 20% improvement, 27% experienced a 50% improvement and 10% experienced a 70% improvement
Carrie Rosenstone
Cohn & Wolfe Healthcare
30 Orange Street, London WC2H 7LZ
Tel: +44 (0)20 7331 5449
Fax: +44 (0)20 7331 9084
The New England Journal of Medicine (NEJM) today publishes a study which offers future hope for the thousands of rheumatoid arthritis (RA) patients who are not responding to currently available treatments (Disease Modifying Anti-Rheumatic Drugs (DMARDs)).
The multicentre study demonstrated that just two doses of MabThera(reg) (rituximab) two weeks apart, in combination with methotrexate (MTX), significantly improved symptoms in patients with severe RA by up to 70%, with response rates sustained for up to one year.
Unlike other RA treatments, MabThera is a targeted treatment that selectively seeks and destroys particular B cells (also known as B-lymphocytes).
"At the National Rheumatoid Arthritis Society we are excited and encouraged by this data. It looks as if MabThera could be an important new option in the future for patients living with Rheumatoid Arthritis in the UK.
Knowing there are other new drugs in the pipeline gives patients who are failing on current therapies hope." Ailsa Bosworth, Chief Executive National Rheumatoid Arthritis Society.
B-cells - a new approach to RA
As research advances into the causes of RA a new approach is emerging. Historically, B cells were considered to contribute to RA - however for much of the past 20 years, it has generally been considered a T-cell mediated disease.
However, new scientific evidence has rekindled a strong interest in B cells, which appear to play an important role in the pathogenesis of RA, suggesting B cells are a promising target for the development of successful treatments.
"The study provides strong support for the idea that B lymphocytes play a central role in rheumatoid arthritis and suggests that B lymphocyte targeted therapy has significant potential", said Professor Jonathan Edwards, University College of London, UK, lead investigator for the study.
MabThera is the only treatment for RA that specifically targets B-Cells.
About the study
In this Phase II study, investigators followed patients for 6 months, with a further observation at 12 months assessing the response with MabThera(reg) alone or in combination with cyclophosphamide or MTX, compared to MTX alone.
The results at 24 weeks showed that the proportion of patients reaching at least a 50% improvement in disease scores (ACR 50 - the primary endpoint) was significantly greater in the MabThera(reg) treated groups compared with the control. Moreover, a significantly higher percentage of patients treated with MabThera(reg) plus MTX achieved a 70% improvement in symptoms (ACR 70).
According to the investigators, the study's safety profile indicates that all three MabThera(reg) regimens were well tolerated with similar levels and type of adverse events compared to MTX alone. Most adverse events were reported during the initial 15 days, with most more likely to occur with the first infusion of MabThera(reg).
The majority of events were of mild to moderate intensity. At week 48, the incidence and types of events, including infections, were evenly balanced across all groups.
About MabThera(reg)
MabThera(reg) (rituximab) is a genetically engineered, therapeutic monoclonal antibody that binds specifically to the CD20 protein found on the surface of B cells.
By selectively targeting B cells, MabThera(reg) breaks the inflammatory cascade of RA - a series of reactions inflaming the joints and leading to the cartilage loss and bone erosion that is characteristic of the disease, the new theory is that B cells play a key role in this inflammatory cascade.
MabThera, known as the 'magic bullet for cancer' has been widely used in clinical practice in the UK for over 6 years for treatment of a form of lymphatic cancer called non-Hodgkin's lymphoma (NHL). More than 370,000 patients worldwide have been treated with MabThera(reg) to date.
Rheumatoid Arthritis
RA affects over 400,000 people in the UK, which is a debilitating disease that hinders the daily activities of sufferers. Although primarily RA affects persons over 64 a significant proportion are aged between 45 and 64.
RA is characterized by inflammation of multiple joints, cartilage loss and bone erosion, which leads to joint destruction and ultimately, reduced joint function. Additionally, since RA is a systemic disease, it can have effects on other tissues, such as lungs, eyes and bone marrow. After ten years of RA, fewer than 50% of patients can continue to work or function normally on a day to day basis. In the UK alone this results in a loss of ??833 million in production costs.
MabThera is not currently licensed for use in rheumatoid arthritis in the United Kingdom
- Ends -
For further information:
Denise Reid-Bashir / Joanna Dixon
Cohn and Wolfe
Tel: +44 20 7331 5337 / +44 20 7331 5321
Mobile: +44 7947 259 41
Rebecca Hunt/Helen Brown
Roche UK
(UK) 01707 367 551/01707 366 805
(UK) 07786 171 214
Notes to editors - results of the NEJM Publication
Response rates at 24 weeks, when using MabThera??? / Rituxan??? in combination with MTX included:
-- 73% of patients showed at least a 20% improvement in symptoms (ACR 20, p=0.003 vs. MTX alone)
-- 43% showed at least a 50% improvement in symptoms (ACR 50 p=0.005 vs MTX alone)
-- 23% showed at least a 70% improvement in symptoms (ACR 70 p=0.048 vs MTX alone)
-- Peripheral blood immunoglobulin levels remained within the normal range throughout and MabThera??? / Rituxan??? was well tolerated with a favorable safety profile
In a further analysis, similar response rates were maintained up to at least 48 weeks without further MabThera??? / Rituxan??? treatment, in the MabThera??? / Rituxan??? plus MTX group, with ACR 20 in 65%, ACR 50 in 35% and ACR 70 in 15%.
Results from the other three arms of the study at 48 weeks include:
-- MTX alone: 20% of patients experienced a 20% improvement in symptoms and 5% experienced a 50% improvement; none experienced 70% improvement
-- MabThera??? / Rituxan??? alone: 33% experienced a 20% improvement, 15% experienced a 50% improvement and 10% experienced a 70% improvement
-- MabThera??? / Rituxan??? and cyclophosphamide: 49% experienced a 20% improvement, 27% experienced a 50% improvement and 10% experienced a 70% improvement
Carrie Rosenstone
Cohn & Wolfe Healthcare
30 Orange Street, London WC2H 7LZ
Tel: +44 (0)20 7331 5449
Fax: +44 (0)20 7331 9084
среда, 17 августа 2011 г.
Vioxx three times as dangerous as Celebrex, study indicates
An independent study carried out at the University of Pennsylvania has shown that your risk of having a heart attack is
three times greater with Vioxx than with Celebrex. Celebrex and Vioxx are both arthritis pain medications (prescription
drugs).
This study is looking at the variations of safety of COX-2 Inhibitors (both Vioxx and Celebrex are COX-2 Inhibitors).
Researchers say further research is needed to identify fully the safety variations among drugs of this class.
Before COX-2 inhibitors were available, people used to take aspirin or ibuprofen for arthritis pain - these drugs caused
serious stomach or intestinal bleeding. The COX-2 Inhibitors were brought in because they were thought of as 'safer'.
People were shocked when some of these new drugs brought with them, as in the case of Vioxx, a high risk of heart attack.
Dr. Stephen Kimmel, study leader, said "At this point the evidence is that there are differences between Vioxx and Celebrex.
Does that mean Celebrex is safe? I cannot tell you…..We compared 1,718 people with non-fatal heart attack to 6,800 people who
did not have heart attacks and asked them about their use of COX inhibitors and NSAIDS."
They found Vioxx was three times as likely to cause a non-fatal heart attack as Celebrex. Kimmel presumes the rates of fatal
heart attacks will also be three times higher for Vioxx.
However, when the researchers examined heart attack rates between Vioxx, Celebrex and NSAIDS they found no difference.
Kimmel commented "That could be because ... we were studying a relatively healthier population. Most people were taking
(Vioxx or Celebrex) for less than 12 months."
Some say it is possible that the risk is only higher for people already at risk of a heart attack. Others say the risks may
be more obvious when patients have been taking the drug(s) over a long period.
The researchers believe that maybe we should only use COX-2 Inhibitors on certain types of people.
What are Cox-2 inhibitors?
COX-2 inhibitors are newly developed drugs for inflammation that selectively block the COX-2 enzyme. Blocking this enzyme
impedes the production of the chemical messengers (prostaglandins) that cause the pain and swelling of arthritis
inflammation. Cox-2 inhibitors are a new class of nonsteroidal anti-inflammatory drugs (NSAIDs). Because they selectively
block the COX-2 enzyme and not the COX-1 enzyme, these drugs are uniquely different from traditional NSAIDs.
What are NSAIDs?
Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed medications for the inflammation of arthritis and other
body tissues, such as in tendinitis and bursitis. Examples of NSAIDs include Aspirin, indomethacin (Indocin), ibuprofen
(Motrin), naproxen (Naprosyn), piroxicam (Feldene), and nabumetone (Relafen).
celebrex
vioxx
View drug information on Vioxx.
three times greater with Vioxx than with Celebrex. Celebrex and Vioxx are both arthritis pain medications (prescription
drugs).
This study is looking at the variations of safety of COX-2 Inhibitors (both Vioxx and Celebrex are COX-2 Inhibitors).
Researchers say further research is needed to identify fully the safety variations among drugs of this class.
Before COX-2 inhibitors were available, people used to take aspirin or ibuprofen for arthritis pain - these drugs caused
serious stomach or intestinal bleeding. The COX-2 Inhibitors were brought in because they were thought of as 'safer'.
People were shocked when some of these new drugs brought with them, as in the case of Vioxx, a high risk of heart attack.
Dr. Stephen Kimmel, study leader, said "At this point the evidence is that there are differences between Vioxx and Celebrex.
Does that mean Celebrex is safe? I cannot tell you…..We compared 1,718 people with non-fatal heart attack to 6,800 people who
did not have heart attacks and asked them about their use of COX inhibitors and NSAIDS."
They found Vioxx was three times as likely to cause a non-fatal heart attack as Celebrex. Kimmel presumes the rates of fatal
heart attacks will also be three times higher for Vioxx.
However, when the researchers examined heart attack rates between Vioxx, Celebrex and NSAIDS they found no difference.
Kimmel commented "That could be because ... we were studying a relatively healthier population. Most people were taking
(Vioxx or Celebrex) for less than 12 months."
Some say it is possible that the risk is only higher for people already at risk of a heart attack. Others say the risks may
be more obvious when patients have been taking the drug(s) over a long period.
The researchers believe that maybe we should only use COX-2 Inhibitors on certain types of people.
What are Cox-2 inhibitors?
COX-2 inhibitors are newly developed drugs for inflammation that selectively block the COX-2 enzyme. Blocking this enzyme
impedes the production of the chemical messengers (prostaglandins) that cause the pain and swelling of arthritis
inflammation. Cox-2 inhibitors are a new class of nonsteroidal anti-inflammatory drugs (NSAIDs). Because they selectively
block the COX-2 enzyme and not the COX-1 enzyme, these drugs are uniquely different from traditional NSAIDs.
What are NSAIDs?
Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly prescribed medications for the inflammation of arthritis and other
body tissues, such as in tendinitis and bursitis. Examples of NSAIDs include Aspirin, indomethacin (Indocin), ibuprofen
(Motrin), naproxen (Naprosyn), piroxicam (Feldene), and nabumetone (Relafen).
celebrex
vioxx
View drug information on Vioxx.
воскресенье, 14 августа 2011 г.
Cost Of Arthritis Dramatically Increases, Reaching $128 Billion Annually
Forty-six million Americans
are currently living with arthritis, the nation's leading cause of
disability, and paying a high price for it. The Centers for Disease Control
and Prevention (CDC) today announced that the annual cost of arthritis to
the United States economy was $128 billion in 2003 and increased by $20
billion between 1997 and 2003.
CDC attributes the dramatic increase to the aging of the population,
predominantly baby boomers, and increased prevalence of arthritis. CDC also
estimates an additional 8 million new cases of arthritis will be diagnosed
in the next decade.
"As the nation's largest private, non-profit contributor to arthritis
research, the Arthritis Foundation is enabling treatment advances that help
millions of people with arthritis better manage their disease," said John
H. Klippel, M.D., president and CEO of the Arthritis Foundation. "Providing
useful information to those with and at risk for getting arthritis is
critical. Through Arthritis Today's 2007 Drug Guide, our efforts to
increase research funding and our exercise and self-help programs, the
Arthritis Foundation is providing people with arthritis the information and
services needed to live healthier lives."
Since 1948, the Arthritis Foundation has spent more than $380 million
to support over 2,000 scientists and physicians in arthritis research. The
Foundation funded $13 million in research in 2006.
Arthritis Today, the consumer health and lifestyle magazine published
by the Arthritis Foundation, offers the 2007 Drug Guide, a free
comprehensive reference to help people make informed decisions in dealing
with the pain of arthritis. The Arthritis Foundation has also reviewed
arthritis research results and created "Top 10 Arthritis Advances 2006."
These information resources are valuable tools for people with
arthritis seeking treatments and therapies to help manage their disease.
More information about the 2007 Drug Guide and the Top 10 Advances of 2006
is available at arthritis - keywords "Get the Facts."
About The Arthritis Foundation
The Arthritis Foundation is the leading health organization addressing
the needs of some 46 million Americans living with arthritis, the nation's
number- one cause of disability. Founded in 1948, with headquarters in
Atlanta, the Arthritis Foundation has 46 chapters and 150 community service
points located throughout the country.
The Arthritis Foundation is the largest private, not-for-profit
contributor to arthritis research in the world, funding more than $380
million in research grants since 1948. The foundation helps individuals
take control of arthritis by providing public health education; pursuing
public policy and legislation; and conducting evidence-based programs to
improve the quality of life for those living with arthritis. Information is
available 24 hours a day, seven days a week at 1-800-568-4045 or
arthritis.
The Arthritis Foundation
arthritis
are currently living with arthritis, the nation's leading cause of
disability, and paying a high price for it. The Centers for Disease Control
and Prevention (CDC) today announced that the annual cost of arthritis to
the United States economy was $128 billion in 2003 and increased by $20
billion between 1997 and 2003.
CDC attributes the dramatic increase to the aging of the population,
predominantly baby boomers, and increased prevalence of arthritis. CDC also
estimates an additional 8 million new cases of arthritis will be diagnosed
in the next decade.
"As the nation's largest private, non-profit contributor to arthritis
research, the Arthritis Foundation is enabling treatment advances that help
millions of people with arthritis better manage their disease," said John
H. Klippel, M.D., president and CEO of the Arthritis Foundation. "Providing
useful information to those with and at risk for getting arthritis is
critical. Through Arthritis Today's 2007 Drug Guide, our efforts to
increase research funding and our exercise and self-help programs, the
Arthritis Foundation is providing people with arthritis the information and
services needed to live healthier lives."
Since 1948, the Arthritis Foundation has spent more than $380 million
to support over 2,000 scientists and physicians in arthritis research. The
Foundation funded $13 million in research in 2006.
Arthritis Today, the consumer health and lifestyle magazine published
by the Arthritis Foundation, offers the 2007 Drug Guide, a free
comprehensive reference to help people make informed decisions in dealing
with the pain of arthritis. The Arthritis Foundation has also reviewed
arthritis research results and created "Top 10 Arthritis Advances 2006."
These information resources are valuable tools for people with
arthritis seeking treatments and therapies to help manage their disease.
More information about the 2007 Drug Guide and the Top 10 Advances of 2006
is available at arthritis - keywords "Get the Facts."
About The Arthritis Foundation
The Arthritis Foundation is the leading health organization addressing
the needs of some 46 million Americans living with arthritis, the nation's
number- one cause of disability. Founded in 1948, with headquarters in
Atlanta, the Arthritis Foundation has 46 chapters and 150 community service
points located throughout the country.
The Arthritis Foundation is the largest private, not-for-profit
contributor to arthritis research in the world, funding more than $380
million in research grants since 1948. The foundation helps individuals
take control of arthritis by providing public health education; pursuing
public policy and legislation; and conducting evidence-based programs to
improve the quality of life for those living with arthritis. Information is
available 24 hours a day, seven days a week at 1-800-568-4045 or
arthritis.
The Arthritis Foundation
arthritis
четверг, 11 августа 2011 г.
A new marker for osteoarthritis
Osteoarthritis (OA) is a common, crippling age-related disease characterized by the gradual destruction of cartilage cushioning the joints. To assess cartilage erosion, doctors routinely rely on measurement of the joint space width using radiographs. To be visible on an X-ray film, however, significant cartilage degradation must have already occurred. By the time radiographs reveal destruction, the damage to the joint is usually irreversible. Due to this method's relatively insensitive nature, it also takes at least a year or two to detect progression of damage that has been captured on radiographs.
To improve the early diagnosis and effective treatment of OA, medical researchers have turned to the promise of biochemical markers - molecules released into bodily fluids during the process of tissue turnover. Recently, researchers in the Netherlands identified a novel marker linked to both the prevalence and the progression of OA, particularly at the knee and the hip. They share their breakthrough findings in the August 2004 issue of Arthritis & Rheumatism.
Building on the analysis of cartilage metabolism, the researchers concentrated on peptide fragments of type II collagen. Since type II collagen is located almost exclusively in cartilage, a fragment - abbreviated as CTX-II - was seen as a potential marker for cartilage destruction. To determine the relationship between CTX-II and OA, researchers drew on a large, established sample: 1,235 men and women ages 55 and older enrolled in the Rotterdam Study, a long-term research effort to investigate the incidence of, and risk factors for, chronic disabling diseases. Researchers followed up with participants, whose average was 66, over a time span of six-and-a-half years.
At the study's onset, 19 percent of the subjects had clear radiographic evidence of OA in at least one knee; 10 percent had OA in at least one hip. At baseline, urine samples from all subjects were assessed for the concentration of CTX-II. The participants were then divided into four groups for further evaluation and continued monitoring, according to their levels of CTX-II.
According to the researchers' calculations, subjects with a CTX-II level in the highest quartile had a 4-fold increased risk of developing OA in either the knee or hip compared with subjects in the lowest quartile. During the follow-up period, confirmed by repeated radiographs, subjects with the highest concentration of CTX-II were significantly more likely to experience rapid, destructive progression of OA - 6 times more likely at the knee and 8 times more likely at the hip. The subjects with the highest CTX-II levels also had the highest complaints of joint pain. In addition, the researchers found a slight rise in CTX-II concentration with increasing age among women. However, the strong correlation between CTX-II and both the incidence and severity of OA was shown to be independent of age, sex, and body mass index.
"This is the first large follow-up study in which the use of CTX-II as a biomarker for cartilage degradation and disease progression has been investigated," emphasizes the team's leading researcher and spokesperson, M. Reijman, MSc. "Based on the results, we conclude that the CTX-II concentration is markedly associated with the prevalence and progression of OA of the knee and hip, and that these associations are independent of known risk factors for radiographic OA. The presence of joint pain seems to augment this relationship," he notes, "which might reflect the effects of an ongoing OA process. The increase of CTX-II in women after menopause may reflect a protective effect of estrogen against cartilage loss. Further research is necessary to establish the clinical utility of this novel biomarker for OA."
Article: "A New Marker for Osteoarthritis: Cross-Sectional and Longitudinal Approach," M. Reijman, J.M.W. Hazes, S.M.A. Bierma-Zeinstra, B.W. Koes, S. Christgau, C. Christiansen, A.G. Uitterlinden, and H.A.P. Pols, Arthritis & Rheumatism, August 2004; Vol. 50; No. 8; pp. 2471-2478.
Contact: David Greenberg
dgreenbewiley
201-748-6484
John Wiley & Sons, Inc.
To improve the early diagnosis and effective treatment of OA, medical researchers have turned to the promise of biochemical markers - molecules released into bodily fluids during the process of tissue turnover. Recently, researchers in the Netherlands identified a novel marker linked to both the prevalence and the progression of OA, particularly at the knee and the hip. They share their breakthrough findings in the August 2004 issue of Arthritis & Rheumatism.
Building on the analysis of cartilage metabolism, the researchers concentrated on peptide fragments of type II collagen. Since type II collagen is located almost exclusively in cartilage, a fragment - abbreviated as CTX-II - was seen as a potential marker for cartilage destruction. To determine the relationship between CTX-II and OA, researchers drew on a large, established sample: 1,235 men and women ages 55 and older enrolled in the Rotterdam Study, a long-term research effort to investigate the incidence of, and risk factors for, chronic disabling diseases. Researchers followed up with participants, whose average was 66, over a time span of six-and-a-half years.
At the study's onset, 19 percent of the subjects had clear radiographic evidence of OA in at least one knee; 10 percent had OA in at least one hip. At baseline, urine samples from all subjects were assessed for the concentration of CTX-II. The participants were then divided into four groups for further evaluation and continued monitoring, according to their levels of CTX-II.
According to the researchers' calculations, subjects with a CTX-II level in the highest quartile had a 4-fold increased risk of developing OA in either the knee or hip compared with subjects in the lowest quartile. During the follow-up period, confirmed by repeated radiographs, subjects with the highest concentration of CTX-II were significantly more likely to experience rapid, destructive progression of OA - 6 times more likely at the knee and 8 times more likely at the hip. The subjects with the highest CTX-II levels also had the highest complaints of joint pain. In addition, the researchers found a slight rise in CTX-II concentration with increasing age among women. However, the strong correlation between CTX-II and both the incidence and severity of OA was shown to be independent of age, sex, and body mass index.
"This is the first large follow-up study in which the use of CTX-II as a biomarker for cartilage degradation and disease progression has been investigated," emphasizes the team's leading researcher and spokesperson, M. Reijman, MSc. "Based on the results, we conclude that the CTX-II concentration is markedly associated with the prevalence and progression of OA of the knee and hip, and that these associations are independent of known risk factors for radiographic OA. The presence of joint pain seems to augment this relationship," he notes, "which might reflect the effects of an ongoing OA process. The increase of CTX-II in women after menopause may reflect a protective effect of estrogen against cartilage loss. Further research is necessary to establish the clinical utility of this novel biomarker for OA."
Article: "A New Marker for Osteoarthritis: Cross-Sectional and Longitudinal Approach," M. Reijman, J.M.W. Hazes, S.M.A. Bierma-Zeinstra, B.W. Koes, S. Christgau, C. Christiansen, A.G. Uitterlinden, and H.A.P. Pols, Arthritis & Rheumatism, August 2004; Vol. 50; No. 8; pp. 2471-2478.
Contact: David Greenberg
dgreenbewiley
201-748-6484
John Wiley & Sons, Inc.
понедельник, 8 августа 2011 г.
Joint Replacement The Second Time Around
Americans are getting more new hip and knee implants than ever before nearly a half-million a year. This boom in joint replacement has made the procedure somewhat routine and widely available. But when it comes time to have that initial implant replaced, due to wear or failure, the procedure is anything but routine, according to an article in the March issue of Cleveland Clinic Arthritis Advisor.
"Revision surgery is a far longer and more complex procedure than initial surgery," says Kenneth Marks, M.D., an orthopaedic surgeon at Cleveland Clinic. "It requires more time and expertise to remove the old implant and do a customized repair and realignment of the existing bone to ensure that the new implant will be held firmly in place."
Growing demand
Though the challenge of revision surgery is higher, the demand is climbing. More and more patients who got their first new hip or knee at age 55 or 60 are outliving the useful life of their implants.
Advanced age is becoming less of an impediment. Even among people 80 and older, the benefits of joint revision surgery pain elimination, increased mobility, greater range of motion can outweigh the risks, as long as you're healthy enough to undergo such surgery in the first place.
Why revision?
Though implants may need to be replaced for a variety of reasons, the most common one is loosening. Loosening starts with the tiny particles that eventually wear off the plastic liner or insert within the hip or knee. As some of these particles slowly find their way to where implant meets bone, they get absorbed by cells (macrophages) capable of triggering bone reabsorption (osteolysis). Over time, this dissolving away of bone leads to implant loosening and pain.
Implant designers have slowed the creation of such particles by using harder, cross-linked plastics, and have nearly eliminated them altogether with newer ceramic-on-ceramic and metal-on-metal designs. The result has been increased implant longevity, meaning implants can now be done earlier to meet the longer lifespan of people who get them.
Other less-common reasons revision surgery may be needed include inadequate bone ingrowth, infection, dislocation, and fracture. When hip implants are inserted without cement, they depend on the growth of bone into the porous surface of the implant over time to ensure stability. Should this process not be fully achieved due to poor bone metabolism, the implant can more easily loosen later.
Infections can also be a cause of hip or knee implant removal, either early on, due to bacteria getting into the incision site, or years later, should blood-borne germs reach the implant and prove resistant to antibiotic therapy. Falls leading to fracture, or dislocation can also necessitate removal and replacement of the implant.
Follow the pain
Increasing pain near the implant, or greater difficulty in placing weight on it are early indications that revision surgery may be needed.
"The location of your pain tells us which part of your implant may be loose," says Dr. Marks. "If it's more of a groin pain, then the acetabular side is likely the problem. If it's more of a thigh pain, then the loosening is typically on the femoral side."
With knee implants, pain just below the knee suggests that the metal implant in the tibia may be loose, but pain that is felt throughout the knee may indicate infection.
Scans show the way
Whatever clues your pain provides need to be confirmed with an X-ray scan. "We can see if there is poor ingrowth on a hip implant, or if the plastic insert in your knee is worn," says Dr. Marks.
If an X-ray suggests serious bone erosion, such that what remains may not be enough to provide sufficient contact between the bone and new implant, a computed tomography (CT) scan will be done to get a more precise view of the erosion. This will help the surgeon determine what needs to be done to repair the damage before proper alignment of a new implant is possible.
Out with the implant
A variety of factors make hip or knee revision surgery a much more lengthy, complex procedure than the initial surgery. "It's not unusual for these surgeries to last five to eight hours or more," says Dr. Marks.
Removing the old implant is a problem not faced the first time around. Not only must the previous device be taken out, but any cement that remains inside the bones must be cleaned out, as well. In hip revisions, the upper shaft of the femur that surrounds the old implant will often be cut away in two or three long sections (osteotomy) to enable implant removal and cleaning of the femoral canal. These pieces later will be reassembled and wired together around the stem of the new implant.
In with bone grafts
The most customized part of a hip or knee revision is the strategy used for restoring the damaged joint surfaces. "There is no one typical way to do this," says Dr. Marks. "It varies with the degree and location of erosion, and the surgeon's experience."
At a minimum, there needs to be at least 50 percent surface contact between bone and the implant for a lasting, secure grip to be possible. Any less and the pits, holes, and other cavities need to be repaired using bone grafts, usually a thick paste of bone chips (morselized bone) made by grinding up cadaver bones.
In a hip revision, bone paste may be used to strengthen the pelvic socket or repair erosion along the inner canal of the femoral shaft. And if the erosion is severe, the socket may need to be rebuilt and reinforced using wire mesh or a titanium ring, in order to regain more normal biomechanics.
In a knee revision, if the end of the femur is weak, even after trimming away damaged bone, the central canal will need to be partially filled with morselized bone. In some cases, metal wedges may be required to better secure the attachment of the new femoral component.
Risks reduced
The many factors that complicate revision surgery less healthy bone, an older patient, greater infection risk, and a customized array of bone, implant, grafts, and support structures mean that it's easier for at least one of these things to go wrong over time.
"Hip and knee revisions typically last about eight to 10 years, compared to the 20 or more years you can expect with a first-time implant," says Dr. Marks.
Though still a serious operation, joint revision is not as fraught with risk as it used to be. "We used to discourage revisions due to obesity, advanced age, and other complications," says Dr. Marks. "But as we've gained experience in limiting the risks, we've become more permissive. As long as you're healthy enough to undergo major surgery, you're healthy enough to have a revision."
WHAT YOU CAN DO
Don't overdo it. Excessive and repetitive overloading of your hip or knee implant can lead to premature loosening.
Let the pain guide you. Increasing pain in the area of your implant is the first indication you may need revision surgery.
Seek a specialist. The complications of revision surgery mean that it's best to seek out a surgeon who does a large number of revisions.
Don't give up on rehab. Though rehab is similar the second time around, it takes longer to regain muscle strength and range of motion due to additional scarring.
Belvoir Media Group, LLC.
7820 Holiday Drive So., Suite 315
Sarasota, FL 34231
United States
belvoir
"Revision surgery is a far longer and more complex procedure than initial surgery," says Kenneth Marks, M.D., an orthopaedic surgeon at Cleveland Clinic. "It requires more time and expertise to remove the old implant and do a customized repair and realignment of the existing bone to ensure that the new implant will be held firmly in place."
Growing demand
Though the challenge of revision surgery is higher, the demand is climbing. More and more patients who got their first new hip or knee at age 55 or 60 are outliving the useful life of their implants.
Advanced age is becoming less of an impediment. Even among people 80 and older, the benefits of joint revision surgery pain elimination, increased mobility, greater range of motion can outweigh the risks, as long as you're healthy enough to undergo such surgery in the first place.
Why revision?
Though implants may need to be replaced for a variety of reasons, the most common one is loosening. Loosening starts with the tiny particles that eventually wear off the plastic liner or insert within the hip or knee. As some of these particles slowly find their way to where implant meets bone, they get absorbed by cells (macrophages) capable of triggering bone reabsorption (osteolysis). Over time, this dissolving away of bone leads to implant loosening and pain.
Implant designers have slowed the creation of such particles by using harder, cross-linked plastics, and have nearly eliminated them altogether with newer ceramic-on-ceramic and metal-on-metal designs. The result has been increased implant longevity, meaning implants can now be done earlier to meet the longer lifespan of people who get them.
Other less-common reasons revision surgery may be needed include inadequate bone ingrowth, infection, dislocation, and fracture. When hip implants are inserted without cement, they depend on the growth of bone into the porous surface of the implant over time to ensure stability. Should this process not be fully achieved due to poor bone metabolism, the implant can more easily loosen later.
Infections can also be a cause of hip or knee implant removal, either early on, due to bacteria getting into the incision site, or years later, should blood-borne germs reach the implant and prove resistant to antibiotic therapy. Falls leading to fracture, or dislocation can also necessitate removal and replacement of the implant.
Follow the pain
Increasing pain near the implant, or greater difficulty in placing weight on it are early indications that revision surgery may be needed.
"The location of your pain tells us which part of your implant may be loose," says Dr. Marks. "If it's more of a groin pain, then the acetabular side is likely the problem. If it's more of a thigh pain, then the loosening is typically on the femoral side."
With knee implants, pain just below the knee suggests that the metal implant in the tibia may be loose, but pain that is felt throughout the knee may indicate infection.
Scans show the way
Whatever clues your pain provides need to be confirmed with an X-ray scan. "We can see if there is poor ingrowth on a hip implant, or if the plastic insert in your knee is worn," says Dr. Marks.
If an X-ray suggests serious bone erosion, such that what remains may not be enough to provide sufficient contact between the bone and new implant, a computed tomography (CT) scan will be done to get a more precise view of the erosion. This will help the surgeon determine what needs to be done to repair the damage before proper alignment of a new implant is possible.
Out with the implant
A variety of factors make hip or knee revision surgery a much more lengthy, complex procedure than the initial surgery. "It's not unusual for these surgeries to last five to eight hours or more," says Dr. Marks.
Removing the old implant is a problem not faced the first time around. Not only must the previous device be taken out, but any cement that remains inside the bones must be cleaned out, as well. In hip revisions, the upper shaft of the femur that surrounds the old implant will often be cut away in two or three long sections (osteotomy) to enable implant removal and cleaning of the femoral canal. These pieces later will be reassembled and wired together around the stem of the new implant.
In with bone grafts
The most customized part of a hip or knee revision is the strategy used for restoring the damaged joint surfaces. "There is no one typical way to do this," says Dr. Marks. "It varies with the degree and location of erosion, and the surgeon's experience."
At a minimum, there needs to be at least 50 percent surface contact between bone and the implant for a lasting, secure grip to be possible. Any less and the pits, holes, and other cavities need to be repaired using bone grafts, usually a thick paste of bone chips (morselized bone) made by grinding up cadaver bones.
In a hip revision, bone paste may be used to strengthen the pelvic socket or repair erosion along the inner canal of the femoral shaft. And if the erosion is severe, the socket may need to be rebuilt and reinforced using wire mesh or a titanium ring, in order to regain more normal biomechanics.
In a knee revision, if the end of the femur is weak, even after trimming away damaged bone, the central canal will need to be partially filled with morselized bone. In some cases, metal wedges may be required to better secure the attachment of the new femoral component.
Risks reduced
The many factors that complicate revision surgery less healthy bone, an older patient, greater infection risk, and a customized array of bone, implant, grafts, and support structures mean that it's easier for at least one of these things to go wrong over time.
"Hip and knee revisions typically last about eight to 10 years, compared to the 20 or more years you can expect with a first-time implant," says Dr. Marks.
Though still a serious operation, joint revision is not as fraught with risk as it used to be. "We used to discourage revisions due to obesity, advanced age, and other complications," says Dr. Marks. "But as we've gained experience in limiting the risks, we've become more permissive. As long as you're healthy enough to undergo major surgery, you're healthy enough to have a revision."
WHAT YOU CAN DO
Don't overdo it. Excessive and repetitive overloading of your hip or knee implant can lead to premature loosening.
Let the pain guide you. Increasing pain in the area of your implant is the first indication you may need revision surgery.
Seek a specialist. The complications of revision surgery mean that it's best to seek out a surgeon who does a large number of revisions.
Don't give up on rehab. Though rehab is similar the second time around, it takes longer to regain muscle strength and range of motion due to additional scarring.
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пятница, 5 августа 2011 г.
Antioxidants May Protect Against Knee Arthritis
People who have diets with plenty of foods containing antioxidants may be protecting themselves from bone changes associated with knee arthritis, according to a new study.
Australian researchers found that middle-aged adults with higher dietary levels of vitamin C were less likely to develop certain bone abnormalities that contribute to knee arthritis.
The findings "highlight the potential of diet to modify the risk of osteoarthritis," they report in the online journal Arthritis Research & Therapy. Dr. Yuanyuan Wang of Monash University in Melbourne led the research.
The subjects were 293 men and women who were middle-aged, healthy and free of knee pain at the start of the study. At that time, they completed detailed questionnaires on their diets; 10 years later, their knee tissue was examined using MRI scans. All of the nutrients were obtained through food, rather than from supplements.
In general, Wang's team found, the higher a person's dietary levels of vitamin C at the start of the study, the lower the risk of certain bone changes 10 years on. The same was true when the researchers looked at overall consumption of fruit, a prime source of vitamin C.
Certain carotenoids, such as the lutein and zeaxanthin found in green vegetables, were also related to a lower risk of cartilage defects in the knee.
Antioxidants protect cells throughout the body from accumulating oxidative damage, which has been shown to play a role in osteoarthritis. Some research has shown the vitamin C boosts bone density, which may explain the benefits seen in this study, the researchers note.
According to experts, the best way to get the full gamut of antioxidants in your diet is to eat a variety of fruits and vegetables every day.
Arthritis Research & Therapy
Australian researchers found that middle-aged adults with higher dietary levels of vitamin C were less likely to develop certain bone abnormalities that contribute to knee arthritis.
The findings "highlight the potential of diet to modify the risk of osteoarthritis," they report in the online journal Arthritis Research & Therapy. Dr. Yuanyuan Wang of Monash University in Melbourne led the research.
The subjects were 293 men and women who were middle-aged, healthy and free of knee pain at the start of the study. At that time, they completed detailed questionnaires on their diets; 10 years later, their knee tissue was examined using MRI scans. All of the nutrients were obtained through food, rather than from supplements.
In general, Wang's team found, the higher a person's dietary levels of vitamin C at the start of the study, the lower the risk of certain bone changes 10 years on. The same was true when the researchers looked at overall consumption of fruit, a prime source of vitamin C.
Certain carotenoids, such as the lutein and zeaxanthin found in green vegetables, were also related to a lower risk of cartilage defects in the knee.
Antioxidants protect cells throughout the body from accumulating oxidative damage, which has been shown to play a role in osteoarthritis. Some research has shown the vitamin C boosts bone density, which may explain the benefits seen in this study, the researchers note.
According to experts, the best way to get the full gamut of antioxidants in your diet is to eat a variety of fruits and vegetables every day.
Arthritis Research & Therapy
вторник, 2 августа 2011 г.
Recommendations For Rheumatoid Arthritis Therapy Presented By American College Of Rheumatology
To manage the painful and incapacitating symptoms of rheumatoid arthritis (RA), a chronic, inflammatory joint disease, the majority of patients rely on disease-modifying antirheumatic drugs (DMARDs). In addition to trusted nonbiologic DMARDs, a number of biologic agents now promise to improve treatment for RA. The American College of Rheumatology (ACR), respected worldwide for its devotion to fostering excellence in patient care, has not updated recommendations for non-biologic DMARDs since 2002 and has not previously developed recommendations for biologic agents. In view of that, ACR decided it was time for a major re-evaluation of the use of DMARD therapy in rheumatoid arthritis.
Under the guidance of a Core Expert Panel of clinicians and methodologists and based on a systematic review of the scientific evidence, a second group of internationally recognized clinicians, methodologists, and patient representatives with extensive expertise in the use of nonbiologic and biologic DMARDs developed these recommendations for the ACR and the results of their work will be presented in the June 2008 issue of Arthritis Care & Research. These recommendations on the use of non-biologic and biologic DMARDs in RA address 5 key areas pre-specified by the ACR: indications for use, monitoring for side-effects, assessing the clinical response, screening for tuberculosis (a risk factor associated with biologic DMARDs), and under certain circumstances (i.e. high disease activity) the roles of cost and patient preference in choosing biologic agents. When developing these recommendations, RA disease duration, disease severity, and prognostic features were also considered.
"These recommendations were developed for specialist clinicians familiar with assessing RA disease activity and disease severity," notes Kenneth Saag, M.D., Professor of Medicine and Epidemiology at The University of Alabama at Birmingham, who co-led the project . "Applying these recommendations to clinical practice requires individualized patient assessment and clinical decision-making. The recommendations developed are not intended to be used in a 'cookbook' or prescriptive manner or to limit a physician's clinical judgment, but rather to provide guidance based on clinical evidence and expert panel input."
The ACR 2008 recommendations for nonbiologic and biologic DMARD use in RA include:
Initiating methotrexate or leflunomide therapy was recommended for most RA patients.
Methotrexate plus hydroxychloroquine was endorsed for patients with moderate to high disease activity.
The triple DMARD combination of methotrexate plus hydroxychloroquine plus sulfasalazine for patients with poor prognostic features and moderate to high levels of disease activity.
Prescribing anti-TNF?± agents - etanercept, infliximab, or adalimumab - along with methotrexate in early RA (less than 3 months) only for patients with high disease activity who had never received DMARDs. In intermediate- and longer-duration RA, anti-TNF?± agents were recommended for patients who had failed to respond adequately to methotrexate therapy.
Reserving the fusion protein abatacept and the B-cell antibody(rituximab) for patients with at least moderate disease activity and poor disease prognosis for whom methotrexate in combination with or sequential administration of other nonbiologic DMARDs led to an inadequate response.
Avoiding the initiation or resumption of treatment with methotrexate, leflunomide, or biologic agents for patients with active bacterial infection, active herpes-zoster viral infection, active or latent tuberculosis, or acute or chronic hepatitis B or C.
Not prescribing anti-TNF?± agents to patients with a history of heart failure, with a history of lymphoma, or with multiple sclerosis or demyelinating disorders.
Avoiding the initiation or resumption of methotrexate, leflunomide, or minocycline for RA patients planning for pregnancy and throughout the duration of pregnancy and breastfeeding.
"These recommendations are extensive but not comprehensive," Dr. Saag acknowledges, "and it is intended that they will be regularly updated to reflect the rapidly growing scientific evidence in this area along with changing practice patterns in rheumatology."
Article: "American College of Rheumatology 2008 Recommendations for the Use of Nonbiologic and Biologic Disease Modifying Antirheumatic Drugs in Rheumatoid Arthritis,"
Kenneth G. Saag, Gim Gee Teng, Nivedita M. Patkar, Jeremy Anuntiyo, Catherine Finney, Jeffrey R. Curtis, Harold E. Paulus, Amy Mudano, Maria Pisu, Mary Elkins-Melton, Ryan Outman, Jeroan J. Allison, Maria Suarez Almazor, S. Louis Bridges, Jr., W. Winn Chatham, Marc Hochberg, Catherine Maclean, Ted Mikuls, Larry W. Moreland, James O'Dell, Anthony M. Turkiewicz, and Daniel E. Furst
Arthritis & Rheumatism (Arthritis Care & Research), June 15, 2008; 59:6, pp. 762-784.
Source: Sean Wagner
Wiley-Blackwell
Under the guidance of a Core Expert Panel of clinicians and methodologists and based on a systematic review of the scientific evidence, a second group of internationally recognized clinicians, methodologists, and patient representatives with extensive expertise in the use of nonbiologic and biologic DMARDs developed these recommendations for the ACR and the results of their work will be presented in the June 2008 issue of Arthritis Care & Research. These recommendations on the use of non-biologic and biologic DMARDs in RA address 5 key areas pre-specified by the ACR: indications for use, monitoring for side-effects, assessing the clinical response, screening for tuberculosis (a risk factor associated with biologic DMARDs), and under certain circumstances (i.e. high disease activity) the roles of cost and patient preference in choosing biologic agents. When developing these recommendations, RA disease duration, disease severity, and prognostic features were also considered.
"These recommendations were developed for specialist clinicians familiar with assessing RA disease activity and disease severity," notes Kenneth Saag, M.D., Professor of Medicine and Epidemiology at The University of Alabama at Birmingham, who co-led the project . "Applying these recommendations to clinical practice requires individualized patient assessment and clinical decision-making. The recommendations developed are not intended to be used in a 'cookbook' or prescriptive manner or to limit a physician's clinical judgment, but rather to provide guidance based on clinical evidence and expert panel input."
The ACR 2008 recommendations for nonbiologic and biologic DMARD use in RA include:
Initiating methotrexate or leflunomide therapy was recommended for most RA patients.
Methotrexate plus hydroxychloroquine was endorsed for patients with moderate to high disease activity.
The triple DMARD combination of methotrexate plus hydroxychloroquine plus sulfasalazine for patients with poor prognostic features and moderate to high levels of disease activity.
Prescribing anti-TNF?± agents - etanercept, infliximab, or adalimumab - along with methotrexate in early RA (less than 3 months) only for patients with high disease activity who had never received DMARDs. In intermediate- and longer-duration RA, anti-TNF?± agents were recommended for patients who had failed to respond adequately to methotrexate therapy.
Reserving the fusion protein abatacept and the B-cell antibody(rituximab) for patients with at least moderate disease activity and poor disease prognosis for whom methotrexate in combination with or sequential administration of other nonbiologic DMARDs led to an inadequate response.
Avoiding the initiation or resumption of treatment with methotrexate, leflunomide, or biologic agents for patients with active bacterial infection, active herpes-zoster viral infection, active or latent tuberculosis, or acute or chronic hepatitis B or C.
Not prescribing anti-TNF?± agents to patients with a history of heart failure, with a history of lymphoma, or with multiple sclerosis or demyelinating disorders.
Avoiding the initiation or resumption of methotrexate, leflunomide, or minocycline for RA patients planning for pregnancy and throughout the duration of pregnancy and breastfeeding.
"These recommendations are extensive but not comprehensive," Dr. Saag acknowledges, "and it is intended that they will be regularly updated to reflect the rapidly growing scientific evidence in this area along with changing practice patterns in rheumatology."
Article: "American College of Rheumatology 2008 Recommendations for the Use of Nonbiologic and Biologic Disease Modifying Antirheumatic Drugs in Rheumatoid Arthritis,"
Kenneth G. Saag, Gim Gee Teng, Nivedita M. Patkar, Jeremy Anuntiyo, Catherine Finney, Jeffrey R. Curtis, Harold E. Paulus, Amy Mudano, Maria Pisu, Mary Elkins-Melton, Ryan Outman, Jeroan J. Allison, Maria Suarez Almazor, S. Louis Bridges, Jr., W. Winn Chatham, Marc Hochberg, Catherine Maclean, Ted Mikuls, Larry W. Moreland, James O'Dell, Anthony M. Turkiewicz, and Daniel E. Furst
Arthritis & Rheumatism (Arthritis Care & Research), June 15, 2008; 59:6, pp. 762-784.
Source: Sean Wagner
Wiley-Blackwell
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